Clinical trial · Observational
Systematic and Mechanism-based Approach to Rational Treatment Trials of Blood Cancer
Systematic and Mechanism-based Approach to Rational Treatment Trials of Blood Cancer (SMARTrial)
NCT03488641CI-TRIAL-00055310SMARTcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This observational study evaluates if drug response testing can be performed within 7 days and analyzes the value of ex-vivo drug screening for hematological malignancies as a biomarker to predict outcome, clinical course and response to treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Diseases | — | UNRESOLVED | — |
| Treatment | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ex-vivo drug response assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of completed drug sensitivity testing
- timeFrame
- 7 days
- description
- Patients' sample (blood, bonemarrow aspirate, tissue of lymphnode) will collected on day 0. Ex-vivo drug sensitivity testing will be performed.
Secondary outcomes (2)
- measure
- Accuracy of patients' drug response prediction by ex-vivo drug profiling
- timeFrame
- from date of inclusion until date of best treatment response (latest 12 months)
- description
- Ex-vivo drug sensitivity categorizes drugs as sensitive/not sensitive. Results will be compared with clinical outcome of patient (response vs. stable disease as defined in the clinical response definition by protocol
- measure
- Prediction of time to next treatment
- timeFrame
- from date of inclusion until change of treatment (latest 12 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of a hematological malignancy: patients with leukemia, myeloma or lymphoma (e.g. ALL, AML, CLL, T-PLL, MCL, MM) who are in need of treatment and are willing to donate sufficient tumor material for ex-vivo drug sensitivity testing. 2. The treating physician needs to indicate treatment. 3. Measurable disease burden according to criteria as mention in section 3. 4. Treatment must be scheduled and the patient must be eligible for the planed treatment as judged by the treating physician. 5. Availability of 5x10e7 cells from peripheral blood draws, bone marrow aspirations or lymph node biopsies. 6. Patient's written informed consent present. 7. Ability to understand the nature of the trial and the trial related procedures and to comply with them. Exclusion Criteria: 1. Any condition, which precludes initiation of treatment (e.g. breast feeding, pregnancy, infections, etc.) as judged by the treating physician. 2. Any coexisting medical or psychological condition that would preclude participation in the required study procedures, as judged by the treating physician. 3. No systemic cancer treatment except for cytoreductive pretreatment within 1 week of enrollment.
References
Publications (1)
- DERIVEDLiebers N, Bruch PM, Terzer T, Hernandez-Hernandez M, Paramasivam N, Fitzgerald D, Altmann H, Roider T, Kolb C, Knoll M, Lenze A, Platzbecker U, Rollig C, Baldus C, Serve H, Bornhauser M, Hubschmann D, Muller-Tidow C, Stolzel F, Huber W, Benner A, Zenz T, Lu J, Dietrich S. Ex vivo drug response profiling for response and outcome prediction in hematologic malignancies: the prospective non-interventional SMARTrial. Nat Cancer. 2023 Dec;4(12):1648-1659. doi: 10.1038/s43018-023-00645-5. Epub 2023 Oct 2. PMID 37783805